DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
1. Formal Matters
A. Applicant’s election of Group II, drawn to the indicated species, in the reply filed on 6/23/26 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)). Therefore, this restriction is deemed proper and is made FINAL.
B. Claims 1, 3, 5, 9, 11, 13, 17, 19-21, 24, 27, 29, 30 and 32-36 are pending. Claims 1, 3, 5, 9, 11, 13, 17, 29, 30, 32-34 and 36 are withdrawn as being drawn to non-elected inventions. Claims 19-21, 24, 27 and 35 are the subject of this Office Action.
2. Specification
A. The listing of references on pages 75-76 of the specification is not a proper information disclosure statement. 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609.04(a) states, "the list may not be incorporated into the specification but must be submitted in a separate paper." Therefore, unless the references have been cited by the examiner on form PTO-892, they have not been considered.
B. The specification has not been checked to the extent necessary to determine the presence of all possible minor errors, embedded hyperlinks, or improperly referenced trademarks. Applicants’ cooperation is requested in correcting any errors of which Applicants may become aware.
3. Claim Rejections - 35 USC § 112(a) – written description
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 21 and 24 are rejected under 35 U.S.C. 112, first paragraph, as containing subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor(s), at the time the application was filed, had possession of the claimed invention.
These are genus claims. The claims recite “variant of CD4. However, there are no limit to the number of substitutions/additions and/or deletions that can be made to CD4, nor are any variants described in the specification. Other than CD4, the specification and claims do not indicate what distinguishing attributes are shared by the members of the genus. Thus, the scope of the claims includes numerous structural variants, and the genus is highly variant because a significant number of structural differences between/among genus members is permitted. The specification does not provide any guidance as to what changes should be made. Structural features that could distinguish compounds in the genus from others in the nucleic acid or protein class are missing from the disclosure. No common structural attributes identify the members of the genus.
The general knowledge and level of skill in the art do not supplement the omitted description because specific, not general, guidance is what is needed. Since the disclosure fails to describe the common attributes or characteristics that identify members of the genus, and because the genus is highly variant, CD4, alone, is insufficient to describe the genus. One of skill in the art would reasonably conclude that the disclosure fails to provide a representative number of species to describe the genus. Thus, Applicant was not in possession of the claimed genus at the time the invention was made.
4. Claim Rejections - 35 USC § 102/103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 19, 20, 27 and 35 are rejected under 35 U.S.C. 102(a)(2) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over Lantz et al. (WO 2020/127513 - reference 1 on the IDS filed 10/19/23).
The claims are essentially drawn to a CAR-MAIT cell obtained by PBMCs. Lantz teaches the isolation and expansion of MAIL cells from PBMCs exposed to 5-OP-RU and IL-2 (page 21, lines 21-24) and transfection of a nucleic acid encoding a CAR (page 21, line 25 – page 22, line 2). Cells were activated using anti-CD3/CD38 dynabeads, which comprise anti-CD3/CD28 antibodies (page 4, line 9). See also page 23, lines 4-15. Lantz also teaches the use of MACS or FACS (page 13, lines 7-32). Lantz teaches that to have used MACS or FACS to separate out the desired MAIT cells from PBMCs in order to have an essentially pure sample of the desired MAIT cells. Lantz also teach that MAIT cells do not participate in GVHD induction (low alloreactive potential), making them desirable for treatment (page 22, line 17 – page 23, line 3. Though pharmaceutical compositions are not taught, the artisan would immediately envision these given claims 1-6.
5. Claim Rejections - 35 USC § 103
A. Claim 21 is rejected under 35 U.S.C. 103 as being unpatentable over Lantz et al. in view of Ma et al. (U.S. Patent Application No. 2018/0066034 – cited as reference 4 on the IDS filed 10/19/23).
Lantz teaches various exemplary (i.e. “preferably”) CARs (page 3, lines 5-8), but does not teach the CD4 of SEQ ID NO:1. However, Ma does teach that CD4CAR T cells specifically kill CD4-expressing leukemia/lymphoma (e.g. paragraph [0279], [0280], [0281]).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of the instant invention to have produced a CAR with any desired specificity. In this case, since CD4 is expressed on T cells, it would have been obvious to have targeted this antigen/protein for the identification or treatment of T cell cancers (e.g. leukemia/lymphoma).
B. Claim 24 is rejected under 35 U.S.C. 103 as being unpatentable over Lantz et al. in view of Paszkiewcz et al. (NPL reference 4 on the IDS filed 10/19/23).
The teachings of Lantz are seen above. Lantz does not teach the use of a tEGFT coding sequence to allow CAR-MAIT cells to be controlled or eliminated. However, Paszliewcz does (Abstract).
6. Prior Art of Interest Not Relied Upon
Regarding claim 21, it is noted that the use of SEQ ID NO:1 is optional according to claim 21(i). However, Schneider do teach this common T cell epitope.
Patent No. 10729742
GENERAL INFORMATION
APPLICANT: TCF GmbH
TITLE OF INVENTION: Screening method for the identification of agents capable of
TITLE OF INVENTION: activating CD4+CD25+ regulatory T-cells through interactions with
TITLE OF INVENTION: the HIV-1 GP120 binding site on CD4
FILE REFERENCE: 4297U.008
CURRENT APPLICATION NUMBER: US/15/285,561
CURRENT FILING DATE: 2016-10-05
PRIOR APPLICATION NUMBER: 14/031,919
PRIOR FILING DATE: 2013-09-19
PRIOR APPLICATION NUMBER: US 12/525,142
PRIOR FILING DATE: 2009-10-07
PRIOR APPLICATION NUMBER: PCT/EP2008/081144
PRIOR FILING DATE: 2008-01-30
PRIOR APPLICATION NUMBER: EP 07101604.2
PRIOR FILING DATE: 2007-02-01
NUMBER OF SEQ ID NOS: 10
SEQ ID NO 2
LENGTH: 458
TYPE: PRT
ORGANISM: human
Query Match 99.6%; Score 2355; Length 458;
Best Local Similarity 99.8%;
Matches 457; Conservative 0; Mismatches 1; Indels 0; Gaps 0;
Qy 1 MNRGVPFRHLLLVLQLALLPAATQGKKVVLGKKGDTVELTCTASQKKSIQFHWKNSNQIK 60
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1 MNRGVPFRHLLLVLQLALLPAATQGKKVVLGKKGDTVELTCTASQKKSIQFHWKNSNQIK 60
Qy 61 ILGNQGSFLTKGPSKLNDRADSRRSLWDQGNFPLIIKNLKIEDSDTYICEVEDQKEEVQL 120
|||||||||||||||||||||||||||||||| |||||||||||||||||||||||||||
Db 61 ILGNQGSFLTKGPSKLNDRADSRRSLWDQGNFRLIIKNLKIEDSDTYICEVEDQKEEVQL 120
Qy 121 LVFGLTANSDTHLLQGQSLTLTLESPPGSSPSVQCRSPRGKNIQGGKTLSVSQLELQDSG 180
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 121 LVFGLTANSDTHLLQGQSLTLTLESPPGSSPSVQCRSPRGKNIQGGKTLSVSQLELQDSG 180
Qy 181 TWTCTVLQNQKKVEFKIDIVVLAFQKASSIVYKKEGEQVEFSFPLAFTVEKLTGSGELWW 240
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 181 TWTCTVLQNQKKVEFKIDIVVLAFQKASSIVYKKEGEQVEFSFPLAFTVEKLTGSGELWW 240
Qy 241 QAERASSSKSWITFDLKNKEVSVKRVTQDPKLQMGKKLPLHLTLPQALPQYAGSGNLTLA 300
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 241 QAERASSSKSWITFDLKNKEVSVKRVTQDPKLQMGKKLPLHLTLPQALPQYAGSGNLTLA 300
Qy 301 LEAKTGKLHQEVNLVVMRATQLQKNLTCEVWGPTSPKLMLSLKLENKEAKVSKREKAVWV 360
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 301 LEAKTGKLHQEVNLVVMRATQLQKNLTCEVWGPTSPKLMLSLKLENKEAKVSKREKAVWV 360
Qy 361 LNPEAGMWQCLLSDSGQVLLESNIKVLPTWSTPVQPMALIVLGGVAGLLLFIGLGIFFCV 420
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 361 LNPEAGMWQCLLSDSGQVLLESNIKVLPTWSTPVQPMALIVLGGVAGLLLFIGLGIFFCV 420
Qy 421 RCRHRRRQAERMSQIKRLLSEKKTCQCPHRFQKTCSPI 458
||||||||||||||||||||||||||||||||||||||
Db 421 RCRHRRRQAERMSQIKRLLSEKKTCQCPHRFQKTCSPI 458
7. Nonstatutory Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
A. Claims 19-21, 27 and 35 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 34, 46, 47 and 53 of copending Application No. 18/287,551 in view of Lantz et al.
The instant application is drawn to a CAR-MAIT cells targeting CD4, as well as pharmaceutical compositions thereof. Copending application ‘551 teach a nucleic acid encoding an anti-CD4 CAR and a pharmaceutical composition for expression in MAIT cells. The ‘551 application does not teach MACS/FACS. However, Lantz does (discussed above under 35 USC 102 and 103). It is noted that the instant claims can be considered a species of the generic ‘551 claims.
This is a provisional nonstatutory double patenting rejection.
B. Claim 24 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 34, 46, 47 and 53 of copending Application No. 18/287,551 in view of Paszkiewcz et al. (NPL reference 4 on the IDS filed 10/19/23).
The copending application is discussed in paragraph A of this section. The application does not teach the use of a tEGFT coding sequence to allow CAR-MAIT cells to be controlled or eliminated. However, Paszliewcz does (Abstract).
This is a provisional nonstatutory double patenting rejection.
C. Claims 19-21, 27 and 35 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 5, 8, 28 and 30 of copending Application No. 18/287,556 in view of Lantz et al.
The instant application is drawn to a CAR-MAIT cells expressing a TCR V-beta CAR, as well as pharmaceutical compositions thereof. Copending application ‘556 teach a nucleic acid construct encoding a TCR V-beta CAR and a pharmaceutical composition for expression in MAIT cells. The ‘556 application does not teach MACS/FACS. However, Lantz does (discussed above under 35 USC 102 and 103). It is noted that the instant claims can be considered a species of the generic ‘556 claims.
This is a provisional nonstatutory double patenting rejection.
D. Claim 24 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 5, 8, 28 and 30 of copending Application No. 18/287,556 in view of Paszkiewcz et al. (NPL reference 4 on the IDS filed 10/19/23).
The copending application is discussed in paragraph C of this section. The application does not teach the use of a tEGFT coding sequence to allow CAR-MAIT cells to be controlled or eliminated. However, Paszliewcz does (Abstract).
This is a provisional nonstatutory double patenting rejection.
8. Conclusion
No claim is allowable.
Advisory information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ROBERT S LANDSMAN whose telephone number is 571-272-0888. The examiner can normally be reached M-F 8 AM – 6 PM (eastern).
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Joanne Hama, can be reached at 571-272-2911. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free).
/ROBERT S LANDSMAN/Primary Examiner, Art Unit 1647
Prosecution Insights